Roth Capital analyst Ed Arce maintained a Buy rating on BioCryst Pharmaceuticals (NASDAQ:BCRX) with a $20 price target, following the news that the FDA has granted the company’s BCX4161 its Fast Track designation, offering earlier and more frequent communication with the Agency.
BCX4161 is a novel, orally available selective inhibitor of plasma kallikrein, currently in an ongoing Phase 2b trial for the prevention of swelling attacks in patients with hereditary angioedema (HAE).
Arce noted, “Ultimately, we believe Rolling Review and Priority Review designations are also likely. Given the established unmet medical need in HAE, we believe the FDA may accept positive OPuS-2 data (expected by YE15) as a single pivotal trial for NDA submission (though we assume another trial), further accelerating ‘4161’s pathway to approval.”
BioCryst Pharmaceuticals, Inc., a biotechnology company, designs, optimizes, and develops small molecule pharmaceuticals that block key enzymes involved in the pathogenesis of diseases.